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FDA 510(k)

GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK

K-Number: K852967 · 1985-08-19

Decision Date1985-08-19
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK is the device name listed in this FDA 510(k) record. The listed applicant is Warner-Lambert Co.. It received FDA 510(k) clearance on 1985-08-19 under 510(k) number K852967. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK?

GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK is a medical device that received FDA 510(k) clearance on 1985-08-19. The listed applicant is Warner-Lambert Co.. The 510(k) number is K852967.

When did GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK receive FDA 510(k) clearance?

GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK received FDA 510(k) clearance on 1985-08-19, under 510(k) number K852967.

Who is the listed applicant for GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK?

The FDA 510(k) record lists Warner-Lambert Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK?

The FDA product code for GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK is JTN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Warner-Lambert Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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